In recent comments to the Environment Protection Agency docket on 1,4-dioxane as one of the first 10 chemicals for risk evaluation, the American Cleaning Institute urges the Agency to focus on actual intended use of ingredients, rather than look at trace byproducts, residues or contaminants in their risk evaluations.

Furthermore, according to ACI, California under Prop. 65 has established a safe harbor limit for 1,4-dioxane. If a product exceeds the Prop. 65 safe harbor limit, it must include a Prop. 65 label warning. The Institute notes that since no company wants such a label on their product, manufacturers are complying with the safe harbor limit, and there is a de facto compliance system by virtue of bounty hunter law firms that regularly examine products and file claims with the State.

In his comments, Paul DeLeo, associate VP-environmental safety, ACI, noted that the Agency’s Preliminary Information document includes links to more than 200 documents, primarily safety data sheets, for a number of materials. According to DeLeo, as a result of this survey, EPA has concluded that it is unlikely that 1,4-dioxane is intentionally used in formulations of currently available commercial and consumer products.

"We agree with this conclusion, and accordingly, we ask that EPA update its websites and associated documents to remove the unintentionally misleading statements that 1,4-dioxane is used in consumer products," said DeLeo. "1,4-dioxane is not used as a deliberately-added ingredient in consumer products and we believe that the Agency’s misstatement is confusing to consumers and implies there are potential risks to consumers due to the potential presence of trace quantities of the substance that might be unintentionally present in certain products at extremely low levels."

In his comments, DeLeo reminded EPA that:
• One, the mere presence of trace quantities of unintended impurities or process residues in certain materials and products does not represent a “condition of use” of 1,4-dioxane.

• Two, the presence of 1,4-dioxane in trace quantities in consumer products does not meet the statutory “may present an unreasonable risk” standard for conducting a risk evaluation under the amended law and
• Three, the Agency has already made a safe use determination with respect to a number of the surfactants that could potentially contain 1,4-dioxane as a byproduct of manufacturing.

"A number of surfactants that would likely contain 1,4-dioxane as residues are on EPA’s Safer Choice Safer Chemical Ingredient List," noted Brian Sansoni, VP-sustainability initiatives, communication & membership, ACI. "By this, it seems they’ve already made a safe use determination and have been encouraging industry and consumers to favor these chemicals for years. It will be interesting to see whether EPA backs up or backs away from SaferChoice."

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